Lilly's Cyramza succeeds in Phase 3 liver cancer study
- Treatment with Eli Lilly & Co.'s cancer drug Cyramza extended survival of liver cancer patients whose disease had progressed following first-line therapy, trial results released by the pharma on April 4 showed.
- In a Phase 3 study called REACH-2, Cyramza met both its overall survival and progression-free survival objectives in certain high-risk patients identified by a biomarker known as alpha-fetoprotein or AFP, Lilly said.
- Lilly plans to submit Cyramza to regulators by mid-year for approval as a second-line treatment of liver cancer. The drug is already indicated in the U.S. for second-line use in stomach, lung and colorectal cancers.
Correction: Cyramza is in development with other agents for gastric, colorectal and biliary tract cancers, not as a monotherapy as was indicated in a previous version of this article.
Liver cancer, or hepatocellular carcinoma (HCC), is the second-leading cause of cancer-related death, and nearly 800,000 patients are diagnosed worldwide each year, according to Lilly. Survival rates for patients whose tumor has spread are low, and second-line treatment options are limited.
Lilly first tested Cyramza as a liver cancer drug in a study called REACH. While the results did not show a survival benefit, further analysis showed those patients with high levels of AFP did better on treatment.
About half of people with advanced liver cancer have elevated AFP, which is a marker of poor prognosis. Seeing the results from REACH, Lilly opted to test Cyramza only in AFP-high patients, forming the basis for REACH-2.
In the study, Lilly enrolled AFP-high patients who had either progressed from or were intolerant to first-line treatment with Bayer AG's Nexavar (sorafenib). Detailed results have not yet been released, but given the survival benefit reported Lilly appears confident in Cyramza's ability to secure an approval.
The REACH-2 results follow Cyramza's earlier successes as a single agent in gastric cancer and in combination with chemotherapy in lung and colorectal cancer.
Cyramza is one of a handful of new drugs Lilly hopes will drive growth as its diabetes portfolio comes under pressure. In a note last month, Cowen analyst Steve Scala pointed to new indications as the foundation of Cyramza's growth potential.
According to Cowen, Cyramza holds a 60% share of the second-line gastric market in Japan and 30% in the U.S. Sales are expected to increase to $825 million in 2018, and are forecast to cross into blockbuster status by 2024.
Lilly is also developing Cyramza in combination with an immune-oncology agent in liver cancer and with other agents in gastric, colorectal and biliary tract cancers. In an ongoing Phase 3 study in advanced urothelial carcinoma, Cyramza has met the primary endpoint of progression-free survival, with overall survival data expected in the first half of 2018.
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